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NCT03941964 · ClinicalTrials.gov registry record · Phase 3
A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
A Phase 3 study of Cancer and Acute Myeloid Leukemia (AML), sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 16
- Study locations
NCT03941964: Completed Phase 3 study of Cancer and Acute Myeloid Leukemia (AML), sponsored by AbbVie.
NCT03941964 is a Phase 3 study of Cancer and Acute Myeloid Leukemia (AML) that has completed, run by AbbVie. The registered enrollment target is 60 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 16 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03941964, a Phase 3 study of Cancer and Acute Myeloid Leukemia (AML), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 16
- Study locations
Study Summary
A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
Primary Outcome
The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) \> 10\^3/μL (1,000/μL), platelets \> 10\^5/μL (100,000/μL), red blood cell (RBC) t
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Decitabine
Study Locations (16)
Texas
- Texas Oncology - Austin Midtown /ID# 212780 - Austin
- Texas Oncology - Medical City Dallas /ID# 211503 - Dallas
- Texas Transplant Institute /ID# 213311 - San Antonio
- Texas Oncology - San Antonio Medical Center /ID# 211510 - San Antonio
- Texas Oncology - Northeast Texas /ID# 213908 - Tyler
Colorado
- Colorado Blood Cancer Institute /ID# 212800 - Denver
- Rocky Mountain Cancer Centers /ID# 211508 - Lone Tree
South Carolina
- Charleston Oncology, P.A. /ID# 211471 - Charleston
- Prisma Health Cancer Inst - Eastside /ID# 211466 - Greenville
Tennessee
- Tennessee Oncology - Chattanooga / McCallie /ID# 212717 - Chattanooga
- Tennessee Oncology-Nashville Centennial /ID# 210944 - Nashville
Arizona
- Arizona Oncology Associates, PC-HOPE /ID# 211509 - Tempe
Indiana
- Fort Wayne Medical Oncology /ID# 223523 - Fort Wayne
Minnesota
- Minnesota Oncology Hematology, PA /ID# 212837 - Minneapolis
Ohio
- Oncology Hematology Care, Inc. /ID# 212779 - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2022-03-14 |
| Phase | Phase 3 |
What the finished NCT03941964 record still lists
NCT03941964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT03941964 lists 16 locations in 9 states (Texas, Colorado, South Carolina).
Frequently Asked Questions
What is clinical trial NCT03941964 about?
NCT03941964 is a clinical study titled "A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy". A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
What is the current status of trial NCT03941964?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2019-08-15. Estimated completion is 2022-03-14.
What conditions does trial NCT03941964 study?
This clinical trial studies the following conditions: Cancer, Acute Myeloid Leukemia (AML).
What interventions are being tested in trial NCT03941964?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Decitabine (DRUG).
Who is sponsoring clinical trial NCT03941964?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03941964 being conducted?
This trial has 16 study locations across Arizona, Colorado, Indiana, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03941964's enrollment target sits among peer trials
60 393rd of 615 higher than 208 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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